Tumor Infiltrating Lymphocyte Therapy for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for patients with gastrointestinal stromal tumors (GIST), which are cancers in the digestive tract that have spread, returned, or cannot be surgically removed. The treatment uses specialized immune cells from the patient's own tumor to help the immune system attack the cancer. It also involves a lab-made protein called aldesleukin to boost the immune response, and patients will receive chemotherapy beforehand to prepare their bodies. The trial seeks participants whose GIST has not responded to other standard treatments or whose disease is locally advanced, recurrent, or metastatic and does not improve with surgery. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Tumor Infiltrating Lymphocyte (TIL) therapy could be promising for cancer treatment. Studies have found that TIL therapy is generally well-tolerated. For instance, one study noted that interleukin-2 (IL-2), used with TILs, was tolerated, with patients usually receiving five doses without any deaths in the first 30 days. However, some serious side effects were reported, mainly due to the chemotherapy given before TIL therapy, not the TILs themselves.
TIL therapy has been successfully used in cancers like melanoma and breast cancer, suggesting it might be safe for other cancers too. The treatment is personalized, using a patient's own cells, which may reduce the risk of certain immune-related side effects compared to other treatments. Overall, while there are some risks, research indicates that many patients tolerate TIL therapy well.12345Why are researchers excited about this trial's treatments?
Tumor Infiltrating Lymphocyte (TIL) Therapy is unique because it harnesses the patient's own immune cells to fight cancer, a method that differs from traditional treatments like chemotherapy and radiation, which target cancer cells more broadly. TIL therapy involves extracting immune cells from the tumor, multiplying them in the lab, and reinfusing them into the patient to enhance their natural ability to attack cancer. Researchers are excited about this treatment because it offers a more personalized approach and has shown promise in targeting tumors that are resistant to standard therapies. Additionally, the use of aldesleukin to boost the effectiveness of TILs is a novel approach that could enhance the immune response further.
What evidence suggests that Tumor Infiltrating Lymphocyte Therapy might be an effective treatment for gastrointestinal stromal tumors?
Research has shown that tumor infiltrating lymphocyte (TIL) therapy can help treat certain cancers, including advanced gastrointestinal stromal tumors (GIST). TIL therapy involves enhancing immune cells taken from a patient's own tumor to help the body fight cancer. In this trial, participants will receive TIL therapy combined with interleukin-2 (aldesleukin), a protein that boosts the immune system. Studies have found that this combination can cause tumors to shrink in some patients. This treatment uses the body's immune system to find and destroy cancer cells. Previous patients with similar conditions experienced promising results with TIL therapy, suggesting it could benefit those with advanced GIST.678910
Who Is on the Research Team?
Joal Beane, MD
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with gastrointestinal stromal tumors (GIST) that have spread, come back after treatment, or are locally advanced. Participants must be able to undergo surgery and other study procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Chemotherapy
Patients receive cyclophosphamide and fludarabine intravenously to prepare for TIL infusion
TIL and Aldesleukin Treatment
Patients receive TIL infusion followed by aldesleukin IV every 8 hours for up to 6 doses
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Aldesleukin
- Cyclophosphamide
- Filgrastim
- Fludarabine
- Tumor Infiltrating Lymphocyte Therapy
Trial Overview
The study tests using a patient's own immune cells (TILs), grown from their tumor, combined with interleukin-2 (aldesleukin). Before this, patients get chemotherapy to prepare the body. The goal is to see if this approach helps fight GIST.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive cyclophosphamide IV over 2 hours on days -8 and -7, fludarabine IV over 30 minutes on days -6 to -2 and TIL IV over 20-30 minutes on day 0 in the absence of disease progression or unacceptable toxicity. Starting within 24 hours of TIL infusion, patients receive aldesleukin IV over 15 minutes every 8 hours for up to 6 doses on days 0-3 in the absence of disease progression or unacceptable toxicity. Starting on day 1 or day 2, patients may receive filgrastim SC until neutrophil count \> 1 x 10\^9/L for 3 consecutive days or \> 5 x 10\^9/L. Patients with stable disease, partial response or recurrence may receive a second course of treatment. Patients also undergo chest x-ray at screening and urine and blood sample collection, CT, MRI or PET throughout the study. Additionally, patients may also undergo echocardiography or MUGA at screening and may also undergo a second surgery to collect cells on study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Joal Beane
Lead Sponsor
Citations
Data
Data is a collection of discrete or continuous values that conveys information, describing the quantity, quality, fact, statistics, other basic units of ...
Data | Open Access Journal
The dataset comprises both raw and quality-controlled genotypic data, as well as phenotypic data in structured format. ... Normative results demonstrate high ...
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Login | data.ai. Sign in with SSO Forgot Password? Create an account with English © 2026 data.ai, a Sensor Tower companyTerms of
Safety and efficacy of combined treatment with tumor ... - PMC
The study demonstrates good tolerability and preliminary efficacy. Keywords: tumor-infiltrating lymphocytes, TIL therapy, oncolytic virus ...
Safety and Efficacy of Tumor-Infiltrating Lymphocyte ...
IL-2 was tolerated with a median of 5 doses and no 30-day deaths. • Response rates were comparable to those with standard lymphodepletion regimens.
8.
oncotarget.com
oncotarget.com/news/pr/tumor-infiltrating-lymphocyte-therapy-offers-a-promising-approach-for-treating-solid-tumors/Tumor infiltrating lymphocyte (TIL) therapy for treating ...
“TIL therapy has been applied successfully in patients with metastatic melanoma, breast cancer, ovarian cancer, cervical cancer, ...
Safety of adoptive therapy with tumor-infiltrating ...
Our primary endpoint was severe adverse events (AEs) of grade 3 or higher. AEs were reported, reported toxicities mainly arising from NMA-LD chemotherapy and ...
Regenerative Medicine - TIL therapy
Specifically, the response rate for TIL therapy in malignant melanoma is approximately 70%, and the complete response rate, where lesions completely disappear, ...
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